BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION FEMORAL AUGMENTATION DISTAL SIZE 2/20MM

    MDR report key: 8826046 · Received July 25, 2019

    Report

    Report Number
    3005180920-2019-00605
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030888892
    PMA / PMN Number
    K163311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 JUL 2019: 2 DEVICE OF LOT 161346 INVOLVED IN THIS COMPLAINT: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2016. EXPIRATION DATE: 20-04-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. TWO ITEMS ARE PRESENT IN THIS COMPLAINT WITH THE SAME LOT NUMBER. VISUAL INSPECTION PERFORMED BY MEDACTA WASHING & PACKAGING MANAGER: THE TWO ITEMS RECEIVED (FEMORAL AUGMENTATION DISTAL) WERE VISUALLY INSPECTED ON JULY 23RD 2019. THE EVENT HAS BEEN CONFIRMED. THE PACKAGING OF ONE ITEM WAS COMPLETELY OPENED WHILE THE SECOND ITEM PACKAGING WAS STILL CLOSED (PRIMARY AND SECONDARY STERILE BARRIER). BOTH ITEMS PRESENTED, INTO THE PRIMARY PACKAGING, SOME WHITE PARTS OF DEBRIS PROBABLY CAME FROM THE PRIMARY TYVEK THAT WAS DAMAGED DUE TO THE CONTACT WITH SCREW AND AUGMENT. IN ADDITION, THE PRIMARY PLASTIC BLISTER WAS SCRATCHED AND IN ONLY ONE ITEM ALSO BROKEN AT THE CORNER, THESE PROBABLY DUE TO EXTREME SHIPPING AND HANDLING CONDITIONS. THE ROOT CAUSE LIKELY RELATES TO THE COMBINED FACTORS OF ANOMALOUS SHIPPING/HANDLING CONDITIONS. THIS IS THE FIRST EVENT REPORTED ON FEMORAL AUGMENTATION; NO ACTION IS AT THE MOMENT FORESEEN.

    Description of Event or Problem · 1

    DURING THE PRIMARY KNEE SURGERY, THE SURGEON OBSERVED A FOREIGN SUBSTANCE ON 2 OF THE FEMORAL DISTAL AUGMENTS AND CHOSE NOT TO IMPLANT THEM IN THE PATIENT. THERE WAS NO DELAY IN THE CASE AND THE SURGEON USED ANOTHER AUGMENT TO COMPLETE THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SAME LOT (2 ITEMS) HAS BEEN USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621358 GMK-REVISION FEMORAL AUGMENTATION DISTAL SIZE 2/20MM KNEE FEMURAL AUGMENTATION KRO MEDACTA INTERNATIONAL SA 161346 07630030888892

    Patients

    Seq Age Sex Outcome Treatment
    1 Other